The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM)

Официальное название

The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM): Rationale and Study Protocol for a Randomized Controlled Trial

Обзор

Type 2 diabetes is associated with progressive loss of muscle mass, which worsens blood sugar control and increases the risk of heart disease and disability. Resistance training (weight training) has been shown to build muscle and improve blood sugar levels, but most existing programmes use high intensities that are difficult for older or inactive people with diabetes to sustain. This study tests a new resistance training programme called D-STORM (Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population), which uses a lower, more manageable training load designed to be safe, tolerable, and effective for adults with Type 2 diabetes who are not on insulin. Participants will be randomly assigned to either twice-weekly D-STORM training plus their usual diabetes care, or usual care alone, for 12 weeks. The main outcome measured is change in HbA1c (a blood test reflecting average blood sugar over 3 months). Body composition, walking capacity, blood pressure, heart rate, and quality of life will also be measured.

Подробное описание

The D-STORM trial is a 2-arm parallel randomised controlled trial conducted at Hospital Sultan Al-Abdullah (HASA), Puncak Alam, Selangor, Malaysia. Adults aged 18 to 65 years with Type 2 diabetes mellitus (HbA1c 6.5% to 13.0%) who are not on insulin therapy will be recruited and randomly allocated 1:1 to the D-STORM intervention arm or the usual care arm.

The D-STORM programme consists of 6 compound resistance exercises performed twice weekly on non-consecutive days for 12 weeks, at 60-80% of one-repetition maximum (1RM), 2 working sets per exercise, using the double progression model with sets terminated at 1-3 repetitions in reserve (RIR).

The primary outcome is between-group difference in HbA1c (%) from baseline to 12 weeks, with a minimum clinically important difference of 1.0% absolute reduction. Secondary outcomes include body composition (bioelectrical impedance analysis; InBody 270), functional exercise capacity (Incremental Shuttle Walk Test), blood pressure, resting heart rate, and health-related quality of life (SF-36). Sample size: 124 participants (62 per arm), accounting for 10% dropout.

Вмешательства

• Поведенческое D-STORM Resistance Training Programme
  Twice-weekly progressive resistance training comprising 6 compound exercises (upper body pull, upper body push, lower body push, lower body pull) at 60-80% 1RM, 2 working sets per exercise per session (minimum 4 sets per muscle group per week), 8-12 repetitions per set, terminated at 1-3 repetitions in reserve. Load is progressively increased using the double progression model. Total intervention duration is 12 weeks.
• Другое usual care
  Participants receive standard diabetes care in accordance with the Malaysian Clinical Practice Guidelines for Type 2 Diabetes Management (6th Edition), including general physical activity recommendations of at least 150 minutes of moderate-intensity aerobic activity per week distributed over at least 3 days, with resistance exercise on a minimum of 2 non-consecutive days per week. No structured, supervised, or progressive training is provided.

Первичные конечные точки

• Glycated Haemoglobin (HbA1c) [Срок оценки: Baseline to 12 weeks]

Вторичные конечные точки (6)

• Body Composition [Срок оценки: Baseline to 12 weeks]
• Functional Exercise Capacity [Срок оценки: Baseline to 12 weeks]
• Blood Pressure [Срок оценки: Baseline to 12 weeks]
• Resting Heart Rate [Срок оценки: Baseline to 12 weeks]
• Health-Related Quality of Life [Срок оценки: Baseline to 12 weeks]
• Exercise Self-Efficacy [Срок оценки: Baseline to 12 weeks]

Критерии участия

Критерии включения

• Aged 18 to 65 years
• Confirmed diagnosis of Type 2 Diabetes Mellitus
• HbA1c between 6.5% and 13.0%
• Not currently on insulin therapy
• Has a primary care provider

Критерии исключения

• Age below 18 or above 65 years
• Blood pressure 160/100 mmHg or higher at screening
• HbA1c below 6.5% or above 13.0%
• Currently on insulin therapy
• Pregnant or planning to become pregnant within the next 6 months
• Serious medical conditions that would prevent safe participation in an exercise programme
• Any physical or functional limitation that would prevent participation in resistance training
• Underlying conditions that would not allow safe participation in the exercise intervention

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Sultan Al-Abdullah (HASA) — Kuala Selangor

Идентификаторы

NCT: NCT07664501 · 600-RMC/MOHE HICoE CARE-I 5/3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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